A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Mural Oncology, Inc
Study ID
NCT02799095
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALKS 4230 — DRUG
    Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
  • ALKS 4230 + pembrolizumab — DRUG
    IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle

Study Details

To better understand the safety and tolerability of ALKS 4230 in humans

Key Dates

Start date
Sep 14, 2016
Status verified
May 2025
Primary completion
Mar 27, 2023
Completion
Aug 2, 2023

Study Design

Enrollment
243 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALKS 4230
  • Experimental: ALKS 4230 + pembrolizumab

Primary Outcome Measure

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Mural Oncology Investigational SiteDenverColorado80045-
Mural Oncology Investigational SitePort Saint LucieFlorida34952-
Mural Oncology Investigational SiteTampaFlorida33610-
Mural Oncology Investigational SiteLexingtonKentucky40536-
Mural Oncology Investigational SiteBostonMassachusetts02215-
Mural Oncology Investigational SiteDetroitMichigan47201-
Mural Oncology Investigational SiteBuffaloNew York14203-
Mural Oncology Investigational SiteNew YorkNew York10016-
Mural Oncology Investigational SiteClevelandOhio44106-
Mural Oncology Investigational SiteDallasTexas75230-
Mural Oncology Investigational SiteFairfaxVirginia22031-
Mural Oncology Investigational SiteSpokaneWashington99208-

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